BC Week In Review | Dec 8, 2017
Clinical News

Bayer's Amikacin Inhale misses in Phase III for Gram-negative pneumonia

Bayer AG (Xetra:BAYN) reported data from the double-blind, international Phase III INHALE program in 725 intubated and mechanically-ventilated patients with Gram-negative pneumonia showing that Amikacin Inhale (BAY41-6551, NKTR-061) plus standard of care (SOC) missed the...
BC Week In Review | Dec 15, 2014
Clinical News

Amikacin Inhale regulatory update

FDA granted Qualified Infectious Disease Product (QIDP) designation to Amikacin Inhale from Bayer to treat Gram-negative pneumonia in intubated and mechanically ventilated patients receiving standard-of-care antibiotics. Bayer has rights to the second-generation nebulizer delivery of...
BC Week In Review | Apr 29, 2013
Clinical News

BAY41-6551: Phase III started

Bayer started the double-blind, placebo-controlled, international Phase III INHALE 1 trial to evaluate 400 mg aerosolized BAY41-6551 given twice daily for 10 days in about 651 patients with Gram-negative pneumonia receiving standard of care IV...
BioCentury | Dec 3, 2012
Regulation

Choice liberates

The judicious way in which FDA asked its Anti-Infective Drugs Advisory Committee whether to approve Theravance Inc. 's Vibativ telavancin to treat hospital-acquired pneumonia last week may reflect what the agency says is its renewed...
BioCentury | Nov 14, 2011
Regulation

Inching toward feasibility

Clinical work on compounds to treat community-acquired bacterial pneumonia and hospital-acquired or ventilator-associated bacterial pneumonia has been in limbo since 2008 when FDA began reassessing its requirements for clinical trial designs, which many companies said...
BioCentury | Sep 28, 2009
Strategy

Nektar's Next Step

Nektar Therapeutics had expected to become profitable in mid-2007 based on royalties from Exubera inhaled insulin. Instead, partner Pfizer Inc. terminated the diabetes drug from its portfolio that October because it failed to gain acceptance...
BC Week In Review | Oct 27, 2008
Company News

Nektar, Novartis deal

Novartis will acquire assets from the pulmonary drug delivery business of Nektar for $115 million in cash. The deal includes Nektar's dry powder and liquid pulmonary delivery technologies and manufacturing assets, plus all manufacturing and...
BioCentury | Oct 27, 2008
Finance

Ebb & Flow

Drug delivery and infectious disease company Nektar (NASDAQ:NKTR) expects to end the year with about $440 million in cash, courtesy of the sale of part of its pulmonary delivery business to Novartis (NYSE:NVS; SWX:NOVN) for...
BC Extra | Oct 22, 2008
Company News

Novartis acquiring Nektar pulmonary assets

Novartis (NYSE:NVS; SWX:NOVN) will acquire assets from the pulmonary drug delivery business of Nektar (NASDAQ:NKTR) for $115 million in cash. The deal includes Nektar's dry powder and liquid pulmonary delivery technologies and manufacturing assets and...
BC Week In Review | May 26, 2008
Clinical News

NKTR-061 Amikacin Inhale: Phase II data

Preliminary data from a double-blind, placebo-controlled Phase II trial in 73 patients with hospital-acquired, Gram-negative pneumonia, showed that Amikacin Inhale had over 1,000 times the lung exposure than IV amikacin. Mean peak tracheal aspirate of...
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